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Randomized Controlled Feasibility Trial of the Fearon Algorithm to Improve Management of Unstable Warfarin

NCT02267408 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-04-06

No results posted yet for this study

Summary

Patients on warfarin but with unstable international normalized ratio (INR) will be recruited to a randomized trial comparing dosing based on an algorithm (Fearon algorithm, named after the mathematician Michael Fearon), which uses historical data to estimate patients' sensitivity to warfarin and to dose changes as well as the lag time until a dose adjustment takes effect, or to the investigators standard management Main outcome is improvement in time in therapeutic range.

Conditions

  • Hypoprothrombinemia

Interventions

OTHER

Warfarin adjustment using the Fearon algorithm

All available historical data will be used to calculate with the Fearon algorithm the individual sensitivity to warfarin and to dose changes as well as lag time until a dose adjustment reaches full effect. Based on this a personal dosing nomogram will be developed and provided to the investigator and to the patients. This nomogram will be used during 6 month but override is possible if the investigator feels that the suggestion from the nomogram is unsafe.

OTHER

Warfarin adjustment using standard dosing

Patients will receive warfarin dosing instructions from a trained nurse using fixed nomograms and computer-based dosing suggestion.

Sponsors & Collaborators

Principal Investigators

  • Sam Schulman, MD, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-02-28
Completion
2017-02-03

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267408 on ClinicalTrials.gov